A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01046266
• Collaborator: (none)
• Enrollment: 62
• Locations: 7
• Arms: 2
• Duration (Months): 31
• Patients Per Site: 8.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is <50.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: RO5083945; Drug: cetuximab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: RO5083945; 700mg iv weekly
Active Comparator: B	Drug: cetuximab; 400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses

Outcome Measures

Primary Outcome Measures

1. immune cell infiltration head and neck squamous cell cancer (HNSCC) [through study completion or early study discontinuation]

Secondary Outcome Measures

1. pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels [through study completion or early study discontinuation]

2. safety and efficacy: AEs, laboratory parameters, tumour assessments [through study completion or early study discontinuation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adult patients, >/=18 years of age

• squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

Exclusion Criteria:

• carcinoma of nasal cavity, paranasal sinus and nasopharynx

• recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

• known positivity for HIV, hepatitis B and/or hepatitis C infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Toulouse		France	31059
2		Villejuif		France	94805
3		Milano	Lombardia	Italy	20162
4		Nijmegen		Netherlands	6525 GA
5		Barcelona		Spain	08035
6		Sevilla		Spain	41013
7		London		United Kingdom	SE1 9RT

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01046266
• Other Study ID Numbers: BP22350; 2009-012656-25
• First Posted: Jan 11, 2010
• Last Update Posted: Sep 14, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Cetuximab

Study Results

No Results Posted as of Sep 14, 2016